BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTRACT UROLIFT SSYTEM

    MDR report key: 12858433 · Received November 22, 2021

    Report

    Report Number
    3015181082-2021-00039
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    September 23, 2021
    Report Date
    November 22, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    10814932020152
    PMA / PMN Number
    K193269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY CAUSING THE CAPSULAR TAB TO BREAK. ON (B)(6) 2021, RETURNED DEVICE ANALYSIS CONFIRMED THAT A 0.25 INCH FRAGMENT WAS MISSING FROM THE CAPSULAR TAB. THE PHYSICIAN WAS INFORMED AND STATED THAT NO ADDITIONAL SCANNING WILL BE PERFORMED AND THE FRAGMENT WAS LIKELY FLUSHED OUT DURING THE PROCEDURE. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751651 NEOTRACT UROLIFT SSYTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM P00510 10814932020152

    Patients

    Seq Age Sex Outcome Treatment
    1 Male